Ampio: Heading in the Right Direction
John is a member of The Motley Fool Blog Network -- entries represent the personal opinion of the blogger and are not formally edited.
Colorado-based Ampio Pharmaceuticals, Inc. has been busy of late. The upward activity and the direction of the stock for this biopharmaceutical company have not been consistent. Perhaps it should be. Current trading is at $2.90, on the bottom end of a 52-week range of $2.61 - $9.27, almost no where to go but the obvious direction.
Ampio develops proprietary drugs for a broad spectrum of afflictions that include inflammation, eye, kidney, and CNS diseases, in addition to metabolic diseases and male sexual dysfunction.
Low risk retooling prior-approved remedies
What is novel about the company’s strategy is that their product pipeline is largely based on developing new uses for previously approved drugs and new molecular entities ("NMEs"). This means that in many cases, the core aspects of their drugs have already passed through the FDA approval process with flying colors, resulting in a significant reduction in developmental costs, as well as time saving in coming to market. This strategy is especially significant if you’re vested in biotechs, biopharmaceuticals, or big pharma. From proof of concept, lab development, pre-clinical-clinical trials of I, II, III, (and don’t forget the skyrocket funding), it’s a 10-12 year game plan before a drug, if successful, ever makes a dime. Meanwhile, shareholders hope and wait, as a company tries to keep the lights on during the process. Failure rates are high, though not imminent; at least not until the cash burn is well underway. So when a novel idea to avert this situation is presented, it’s worth a look – worth a risk to many – a payoff could be had, much quicker than with the conventional approach.
Study results for osteoarthritis
The company announced the completion of the planned analysis of the day 84 data of the Ampion in the Knee (AIK) study. Prior to this announcement, the company reported positive results 30 days after a single injection to the knees of patients suffering from osteoarthritis. This study was designed to explore safety and efficacy in a proof of principle. Conducted in Australia, it was extended to also review pain outcomes at day 84 after the injection. The company observed prolonged and sustained pain relief in the Ampion treated group even after 84 days from a single injection into the knee and the safety profile was good.
Ampion is a molecule protected by a composition of matter and use patents. It is naturally produced by humans and produces itself as a response to injury. It is present in commercial human serum albumin (HSA) preparations. Because HSA and blood-derived products are currently managed by the Center for Biologics Evaluation and Research division of the FDA, company officials believe this product will be classified as a biologic. Ampion is a non-steroidal anti-inflammatory drug that appears to have a significant role in the homeostasis of inflammation, so that it has the potential to be used in a broad array of inflammatory conditions, which impact millions of patients.
Patent activity
Recently company activity includes receiving notice of allowance of a patent from the US Patent and Trademark Office for its DME drug Optina. Optina is an ultra low dose of danazol, for the treatment of diabetic macular edema (DME). They also received a notice of allowance of a similar patent, from the Canadian Intellectual Property Office. Collectively, these initial patents cover the North American territories, and multiple additional patents for using Optina for the treatment of macular edema and diabetic retinopathy are pending worldwide. The patents carry an unusually long period of protection, this one until 2030, thus potentially providing a very long revenue stream. Ampio is currently in discussions with potential partners to co-develop Optina for DME.
Clinical trial enrollment success
Ampio also recently enrolled patients in its multiple indication diagnostic clinical trials. The trials revolve around patients entering hospital emergency rooms with chest pain and subsequently undergoing clinical evaluation that includes the performance of Positron Emission Tomography coupled with Computerized Axial Tomography (PET/CT). This is to detect the presence or absence of multiple afflictions including myocardial ischemia. In the trial 523 patients were enrolled for myocardial ischemia, stroke symptoms encompassed 850 patients enrolled, as well as traumatic brain injury (of which the company already acquired data from 3,500 enrolled patients). The analysis trial results will determine the clinical utility of the technology, and the company is expected to prepare a 510(k) submission upon completion of data analysis.
With a smart strategy, low development cost, strong IP, and forward moving results in small group settings, this just under $100M company shows opportunities to profit from.
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